Decanoic acid, monoester with glycerol

Endpoint summary

Description of key information

Skin irritation/corrosion (read-across OECD 404): not irritating

Eye irritation (read-across OECD 405): not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Remarks:

Summary of available data used for the endpoint assessment of the target substance

Adequacy of study:

weight of evidence

Justification for type of information:

refer to analogue justification provided in IUCLID section 13

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

erythema score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0.23

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: Source: CAS 97593-30-1

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: Source: CAS 97593-30-1

Further data available for CAS 73398-61-5:

Erythema score (24/48/72 h): 0/4 for all 6 animals, respectively

Edema score (24/48/72 h): 0/4 for all 6 animals, respectively

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

Conclusions:

The read-across application is justified in the analogue justification. Based on the available data, the target and source substances are considered not to show differences in skin irritation properties. The available data on suitable source substances did not show any skin irritation effects. Therefore, the target substance is not predicted to be a skin irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Remarks:

Summary of available data used for the endpoint assessment of the target substance

Adequacy of study:

key study

Justification for type of information:

refer to analogue justification provided in IUCLID section 13

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: Source: CAS 97593-30-1

Irritation parameter:

iris score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

other: Source: CAS 97593-30-1

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

out of 3 animals

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: Source: CAS 97593-30-1

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

out of 3 animals

Time point:

24/48/72 h

Score:

0.2

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: Source: CAS 97593-30-1

Further data are available for source CAS 142-18-7:

cornea opacity score (24/48/72 h; mean for all 6 animals): 0.28/4, fully reversible within 5 days at the latest

iris score (24/48/72 h): 0/2 for all 6 animals, respectively

conjuctivae score (24/48/72 h; mean for all 6 animals): 1.33/3, fully reversible within 5 days at the latest

mean chemosis score (24/48/72 h; mean for all 6 animals): 0.5/4, fully reversible within 5 days at the latest

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

Conclusions:

The read-across application is justified in the analogue justification. Based on the available data, the target and source substances are considered not to show differences in eye irritation properties. The available data on suitable source substances did not show any eye irritation effects. Therefore, the target substance is not predicted to be an eye irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Read-across justification

There are no available data on skin and eye irritation of Esterification product of glycerol and C8-C12 (even numbered) fatty acids (old CAS: 26402-22-2). The assessment was therefore based on studies conducted with analogue substances as part of a read across approach, which is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. For each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).

 

Skin irritation

CAS 97593-30-1

The skin irritation potential of Glycerides, C8-21 and C8-21-unsatd., mono- and di-, acetates was investigated in a study performed according to OECD guideline 404 and under GLP conditions (WoE, 2008). 0.5 mL of the undiluted test substance was applied to the dorsal skin of 3 female Crl:KBL(NZW)BR rabbits under semiocclusive conditions. In the initial test, one female was exposed to the test substance for 3 min, 1 h and 4 h. As no corrosive effect was observed in the initial test, a confirmatory test was performed using two additional animals treated with the test substance for a period of 4 h. Skin reactions were assessed 1, 24, 48 and 72 h after removal of the test substance. In 2/3 animals, slight erythema (score 1) was observed 1 h after test after exposure. In one of these animals, the slight erythema persisted until the 48-h reading time point, and was fully reversible within 72 h. In the other 2 animals, no erythema was seen 24, 48 and 72 h after patch removal. No edema occurred in any of the tested animals at any reading time point. No signs of systemic toxicity were observed. The mean erythema and edema scores over the 24, 48 and 72 h reading time points were 0.67, 0 and 0, respectively. The test substance is considered to be not irritating to the skin.

CAS 73398-61-5

The skin irritation potential of Triglycerides, mixed decanoyl and octanoyl was assessed in a study conducted according to OECD guideline 404 and under GLP conditions (WoE, 1988). 0.5 mL of the undiluted test substance was applied for 4 h to the shaved skin of 6 New Zealand White rabbits, under semiocclusive conditions. The scoring of skin reactions (erythema and edema) was performed 1, 24, 48 and 72 h after removal of the dressing. The test item did not cause any skin reactions at the application site of any animal at any of the reading time points. All erythema and edema scores were 0 for all 6 animals. No signs of systemic toxicity were seen. Therefore, the test substance is considered to be non-irritating to the skin.

 

Eye irritation

CAS 97593-30-1

An eye irritation study was performed with C12: Glycerides, C8-21 and C8-21-unsatd., mono- and di-, acetates according to OECD guideline 405 and under conditions of GLP (Key, 2008). The undiluted test substance (0.1 mL) was installed into one eye of 3 female Crl:KBL(NZW)BR rabbits each. The other eye remained untreated and served as control. Examination and scoring of effects on the eyes was performed at intervals of 1, 24, 48 and 72 h after test substance application. 1 h post-instillation, moderate conjunctival redness and very slight chemosis were observed in all 3 animals. Slight conjunctival redness and very slight chemosis were observed at the 24 h reading time point in 3/3 and 2/3 animals, respectively. Both effects were fully reversible after further 24 h (48 h reading time point). No corneal opacity or iritis was noted in any animal at any reading time point. No further local or systemic toxic effects were observed. The mean cornea and iris scores after 24, 48, and 72 h were 0 for all 3 animals. The mean scores for conjunctivae and chemosis over 24, 48, and 72 h were 0.3, 0.0 and 0.3 and 0, 0.3 and 0.3 for the 3 animals, respectively. Thus, the test substance was not considered to be eye irritating.

CAS 142-18-7

An eye irritation study was conducted with 2,3-dihydroxypropyl laurate according to the national FDA guideline "Appraisal of the safety of chemicals in foods, drugs and cosmetics" (Key, 1977). The solid test material (0.1 g) was placed into the conjunctival sac of the left eye of 6 New Zealand White rabbits each. The other eye remained untreated and served as control. The eyes were examined and scored 1, 24, 48 and 72 h as well as 4, 5, 6 and 7 days after application. At the 1, 2 and 8 h reading time points, no corneal opacity and iritis were observed. At this time points, slight to moderate conjunctival redness and moderate to strong chemosis and discharge were seen in all animals. 24 h post-application, corneal opacity was observed in 2/6 animals which was fully reversible within 72 h and 96 h, respectively. Slight to moderate conjunctival redness was observed in all animals 24 h post-application. These effects were fully reversible within 48 h (1/6 animals), 72 h (1/6 animals) or 5 days (4/6 animals). Slight to strong discharge was observed in all animals 24 h post-application. These effects were fully reversible within 72 h (5/6 animals) or 4 days (1/6 animals). Test substance application into the rabbit eye induced no iridial effects at any observation time point; scores were all 0. Over 24, 48 and 72 h the mean cornea scores were 0, 0, 0, 0, 1 and 0.7, chemosis scores were 1, 1, 1, 0.3, 1 and 1.7 and conjunctivae scores were 1.7, 1.3, 1, 0.3, 2 and 1.7 for the 6 animals, respectively. No further local or systemic toxic effects were observed. Therefore, the test substance was not considered to be eye irritating.

 

Overall conclusion for skin and eye irritation

The available data on suitable source substances did not show any skin or eye irritation effects. Therefore, the target substance Esterification product of glycerol and C8-C12 (even numbered) fatty acids (no CAS) is not expected to be a skin irritant or an eye irritant.

Justification for classification or non-classification

According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". Since the analogue concept is applied to Esterification product of glycerol and C8-C12 (even numbered) fatty acids, data will be generated from reference source substance(s) to avoid unnecessary animal testing. Additionally, once the analogue read-across concept is applied, substances will be classified and labelled on this basis.

Therefore, based on the analogue read-across approach, the available data on skin and eye irritation do not meet the classification criteria according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.